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NCT07124910 · ClinicalTrials.gov registry record · Phase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
A Phase 3 study of Keratoconus and Pellucid Marginal Corneal Degeneration, sponsored by Woolfson Eye Institute.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 485
- Enrollment target
- 12
- Study locations
NCT07124910: Recruiting Phase 3 study of Keratoconus and Pellucid Marginal Corneal Degeneration, sponsored by Woolfson Eye Institute.
NCT07124910 is a Phase 3 study of Keratoconus and Pellucid Marginal Corneal Degeneration that is actively recruiting participants, run by Woolfson Eye Institute. The registered enrollment target is 485 participants, below the 1,157-participant average among 21 other Keratoconus trials with a reported enrollment target (58% lower). The trial reports 12 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07124910, a Phase 3 study of Keratoconus and Pellucid Marginal Corneal Degeneration, is actively recruiting participants, sponsored by Woolfson Eye Institute.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 485 participants
- Enrollment target
- 12
- Study locations
Study Summary
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light). * There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.
Primary Outcome
The change in keratometry (Kmax) and corrected visual acuity from baseline will be evaluated at 6 months for all eyes treated. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests. The change in Kmax and corrected visual acuity from baseline will be evaluated at 6 months.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Epi-ON corneal cross-linking
Study Locations (12)
Georgia
- Woolfson Eye Institute - Atlanta
- Woolfson Eye Institute - Atlanta
- Woolfson Eye Institute - Canton
- Woolfson Eye Institute - Cumming
- Woolfson Eye Institute - Douglasville
- Woolfson Eye Institute - Lawrenceville
- Woolfson Eye Institute - Marietta
- Woolfson Eye Institute - Snellville
Tennessee
- Woolfson Eye Institute - Chattanooga
- Woolfson Eye Institute - Johnson City
- Woolfson Eye Institute - Knoxville
North Carolina
- Woolfson Eye Institute - Asheville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT07124910 shows while recruiting
NCT07124910 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, below the 1,157-participant average among 21 other Keratoconus trials with a reported enrollment target (58% lower).
The record links to 4 conditions, with Keratoconus appearing as the primary indexed condition, and to 1 intervention - of which Epi-ON corneal cross-linking is the first listed.
NCT07124910 lists 12 locations in 3 states (Georgia, Tennessee, North Carolina).
Frequently Asked Questions
What is clinical trial NCT07124910 about?
NCT07124910 is a clinical study titled "Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases". The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performe...
What is the current status of trial NCT07124910?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2025-08-01. Estimated completion is 2028-12-31.
What conditions does trial NCT07124910 study?
This clinical trial studies the following conditions: Keratoconus, Pellucid Marginal Corneal Degeneration, Ectasia of Cornea, Forme Fruste Keratoconus (FFK).
What interventions are being tested in trial NCT07124910?
The interventions under investigation include: Epi-ON corneal cross-linking (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07124910?
This trial is sponsored by Woolfson Eye Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07124910 being conducted?
This trial has 12 study locations across Georgia, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Keratoconus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07124910's enrollment target sits among peer trials
485 4th of 21 higher than 18 of 21 other Keratoconus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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